The FDA has cleared Dexcom’s Stelo Glucose Biosensor System for use by people ages 2 and older who do not use insulin. The decision, announced June 12, makes Stelo the first over-the-counter continuous glucose monitor approved for children.
The clearance extends Stelo’s reach beyond its original March 2024 approval for adults. The device pairs a wearable sensor with a smartphone app that shows glucose values and trends every 15 minutes. Each sensor lasts up to 15 days, though wear time can be shorter in children.
Stelo is intended for people tracking glucose patterns through oral diabetes medication or daily routines. It is not approved for insulin users, people with problematic hypoglycemia, or those on dialysis, and it does not provide low-glucose alerts.
For children, the FDA requires use under adult caregiver supervision. Schools and health care teams will need to address policies for phone access, app connectivity, and data response during the school day.
Pricing and reimbursement details remain to be confirmed as the product rolls out.
